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Completed

NCT Number: NCT02587832

High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Microcephaly, Primary Autosomal Recessive, 6 Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akron Children's Hospital

Akron, Ohio, 44308, United States

About this study

Inclusion criteria

were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion criteria

were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm neonates with gestational age of 24 to 28 completed weeks.
  • In the case of twins, both neonates were included in the same treatment arm.
  • Success to wean with 24 hours to extubate.
  • Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion criteria

  • Evidence of severe birth asphyxia.
  • Known genetic or chromosomal disorders.
  • Infants delivered to mothers with ruptured membranes of more than three weeks duration.
  • Potentially life-threatening conditions unrelated to prematurity.
  • Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Treatment and study plan

HHHFNC

Device

Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified

Other names: VAPOTHERM

NCPAP

Device

Bubble CPAP System.

Primary outcomes

  1. the need for re-intubation

    Time frame: 5 DAYS

    The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.

Secondary outcomes

  1. Duration of respiratory support using HHHFNC /NCPAP.

    Time frame: through study completion, an average of 1 year.

  2. Incidence of nasal breakdown

    Time frame: through study completion, an average of 24 weeks

  3. sepsis

    Time frame: through study completion, an average of 1 year.

  4. intraventricular hemorrhage (IVH),

    Time frame: through study completion, an average of 24 weeks

  5. retinopathy of prematurity (ROP)

    Time frame: through study completion, an average of 24 weeks

    number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens.

Sponsors and collaborators

Lead sponsor

Sidra Medicine

Other

Collaborators

  • Akron Children's Hospital

Registry information

Official study title

Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2015
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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